Status:
RECRUITING
Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
This observational study wants to examine the disease progression independent of relapses in patients with Multiple Sclerosis (MS) that are treated with monoclonal antibodies. Participants will be cli...
Detailed Description
The goal of this observational prospective, observational, multicenter proof of concept study is to identify silent disease progression in people with multiple sclerosis (MS) that are treated with mon...
Eligibility Criteria
Inclusion
- Diagnosis of RRMS or PPMS according to the 2017 McDonald criteria
- Current treatment with monoclonal antibodies (including Natalizumab, Ofatumumab, Ocrelizumab) according to SmPC
- EDSS ≤7.0
Exclusion
- Patients with an acute MS relapse and/or a history of intravenous corticosteroid treatment within past six weeks.
- Any comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementia. Decision will be made at investigators discretion.
- Additional immunosuppression except of above mentioned monoclonal antibodies
- Pregnancy
Key Trial Info
Start Date :
June 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT06501950
Start Date
June 20 2024
End Date
December 1 2027
Last Update
July 15 2024
Active Locations (1)
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1
University Hospital Düsseldorf, Department of Neurology
Düsseldorf, North Rhine-Westphalia, Germany, 40225